Could Myriad be forced to license BRCA testing in US?

22 July 2013

The chair of the US Senate Judiciary Committee has reportedly asked National Institutes of Health (NIH) Director Francis Collins to use a legal provision to compel Myriad Genomics to offer licenses for BRCA testing on reasonable terms.

Although the US Supreme Court recently ruled that elements of Myriad’s US patent claims for the BRCA1 and BRCA2 genes were invalid (see previous news), many remain in place and the company has already defended them against other companies with lower-priced BRCA testing products (see Genomics Law Report).

The 1980 Bayh-Dole Act, intended to allow commercialisation of federally funded research via licensing, includes provision for ‘march-in rights’ – enabling the federal government to directly grant licenses for patents if the patent holder will not grant them on reasonable terms in situations such as where it is deemed necessary ‘to alleviate health or safety needs which are not reasonably satisfied’. March-in rights have never been enforced.

Senator Patrick Leahy has suggested that such a move would be justified to ensure wider access to genetic testing for inherited susceptibility to breast and ovarian cancer, since Myriad may otherwise continue to hold a monopoly on this testing, which costs up to $4,000 and this is an effective barrier to testing for many women.

A Myriad spokesman said that the company was expanding financial assistance for poorer patients without access to testing via health insurance, commenting: "Myriad’s BRCA test is widely accessible and reimbursed and march-in rights are inappropriate and unnecessary in this case…As of today, BRCA testing is widely covered by public and private insurance for the vast majority of at-risk patients, and their average out-of-pocket cost is less than $100”.

Comment: Predictions that the Supreme Court decision would lead to lower prices and increased access to BRCA genetic testing in the US appear to have been correct; although Myriad clearly wishes to remain the sole provider, the mere threat of compulsory licensing appears to have stimulated a widening of access. Another key factor may be uptake by health insurers; will they reach a pricing agreement with Myriad, or would they too prefer a wider marketplace?